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A Phase 3 Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (13 to 17 years of age)
EU CTIS ID: 2025-523711-11-00
What this study is testing
To determine if KarXT is better than placebo (“dummy drug” with no medicine) in reducing the symptoms of schizophrenia in teenagers (13-17 years old)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must be 13 to 17 years of age, inclusive, at the time of signing the ICF
- Participants' legally acceptable representative (ie, legal guardian or caregiver) must have signed and dated an IRB/IEC-approved ICF in accordance with regulatory, local, and institutional guidelines
- Participants with diagnosis of schizophrenia as defined by the DSM-5-TR criteria and experiencing symptoms of psychosis during screening
- IOCBP must have a negative highly sensitive serum pregnancy test at screening and a urine test within 24 hours prior to the start of study intervention
- Participants must agree to follow instructions for highly effective method(s) of contraception as described in the protocol and included in the ICF
- Participants in a stable living condition and are expected to remain at the same location for the duration of the trial
You likely can't join if
- Participants with any primary DSM-5-TR disorder diagnosis other than schizophrenia within 12 months before screening including, but not limited to moderate to severe alcohol use disorder, substance (other than nicotine or caffeine) use disorder, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and post-traumatic stress disorder
- Participants who are showing inability to tolerate oral medication or swallow capsules
- Participants with a history or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease
- Participants with any neurological disorder, except for Tourette’s Syndrome
- Participants with uncontrolled diabetes or clinically significant abnormal fasting blood glucose level at screening
- Participants who have been diagnosed with epilepsy, or have a history of seizures, severe head trauma or stroke
See the full eligibility criteria
- Participants must be 13 to 17 years of age, inclusive, at the time of signing the ICF
- Participants' legally acceptable representative (ie, legal guardian or caregiver) must have signed and dated an IRB/IEC-approved ICF in accordance with regulatory, local, and institutional guidelines
- Participants with diagnosis of schizophrenia as defined by the DSM-5-TR criteria and experiencing symptoms of psychosis during screening
- IOCBP must have a negative highly sensitive serum pregnancy test at screening and a urine test within 24 hours prior to the start of study intervention
- Participants must agree to follow instructions for highly effective method(s) of contraception as described in the protocol and included in the ICF
- Participants in a stable living condition and are expected to remain at the same location for the duration of the trial
- Participants with any primary DSM-5-TR disorder diagnosis other than schizophrenia within 12 months before screening including, but not limited to moderate to severe alcohol use disorder, substance (other than nicotine or caffeine) use disorder, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and post-traumatic stress disorder
- Participants who are showing inability to tolerate oral medication or swallow capsules
- Participants with a history or presence of clinically significant cardiovascular, pulmonary, hepatic impairment, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease
- Participants with any neurological disorder, except for Tourette’s Syndrome
- Participants with uncontrolled diabetes or clinically significant abnormal fasting blood glucose level at screening
- Participants who have been diagnosed with epilepsy, or have a history of seizures, severe head trauma or stroke
- Participants who have a significant risk of committing violent acts, serious self-harm, or attempting suicide
- Participants with prior exposure to KarXT(xanomeline-trospiumchloride)
- Participants who experienced any adverse effects due to xanomeline or trospiumchloride
- Participants with any clinically significant abnormal laboratory test results at Visit 1 (screening) as per investigator discretion
The study team makes the final eligibility decision.
Where it's taking place
- Colombia
- United States
- Japan
- Mexico
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombia; United States; Japan; Mexico; Argentina. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.